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Agendia Achieves ISO Certification

NEW YORK (GenomeWeb News) – Agendia today said that its facilities in Irvine, Calif., and Amsterdam have received ISO 13485 certification.

The firm said that the certification recognizes that its Symphony diagnostic services, including the MammaPrint, BluePrint, TargetPrint, and TheraPrint products meet "the highest internationally recognized quality standards," and confirms the quality of the design and development of Agendia's current and future diagnostic services.

In order to get ISO 13485 certification a company's quality management system needs to demonstrate that it can consistently meet customer and regulatory requirements. "The primary objective of ISO 13485 is to harmonize regulatory requirements for quality management systems globally and includes an emphasis on process control and effectiveness for design, development, manufacture, risk management, and distribution of related medical services," Agendia said.

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